Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients

NCT ID: NCT01313273

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-06-30

Brief Summary

The aim of the study is to compare in an exploratory fashion the efficacy on progression-free survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non metastatic castrate resistant prostate cancer patients.

Detailed Description

LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Group Type: OTHER

Non steroidal anti androgens and LHRH-a

Intervention Type: DRUG

Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression

Arm B

Group Type: EXPERIMENTAL

Lanreotide, non steroidal anti androgens and LHRH-a

Intervention Type: DRUG

Lanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months.

Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression.

Interventions

Lanreotide, non steroidal anti androgens and LHRH-a

Lanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months.

Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression.

Intervention Type: DRUG

Non steroidal anti androgens and LHRH-a

Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically proven diagnosis of prostate cancer
• Evidence of PSA progression despite castrate levels of testosterone (<50 ng/dL) following orchiectomy or during therapy with luteinizing hormone releasing hormone agonists (LHRH-a)
• Patients with non-metastatic or stable metastatic disease
• Chromogranin A elevation above normal range (confirmed by a second evaluation at least 1 week later) [cut off levels will be > 20 U/L for enzyme linked immunosorbent (ELISA) assay and > 100 ng/ml for immunoradiometric (IRMA) assay]

Exclusion Criteria

• Patients who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel)
• First line treatment with antiandrogen in monotherapy
• Visceral metastasis
• Previous or concomitant treatment with a somatostatin analogue

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

A.O. S. Luigi Gonzaga

Orbassano ( TO), , Italy

Countries

Italy

Other Identifiers

2010-019862-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A-93-52030-738

Identifier Type: -

Identifier Source: org_study_id